Why partering with a certifier for cleanroom testing makes sense

A Clean(room) Partnership: Working With a Certifi er

Having a strong working partnership with a certification company is critical for developing a workable cleanroom testing protocol, according to two sterile compounding veterans. Knowing the limits of your staff’s expertise in this area, coupled with an ability to troubleshoot key compliance gaps, can go a long way toward ensuring success, they noted during separate conferences on sterile compounding.

The first key step is “to know that your cleanroom is in a state of control for the protection of your employees and your patients,” said Lisa Ashworth, BSPharm, RPh, a clinical pharmacist at Children’s Health System of Texas, in Dallas, during the “Cleanovators” virtual summit presented by Contec. “We’re pharmacists and pharmacy technicians; we’re not architects or engineers, and we’re not certified to perform cleanroom testing. Although I do know some hospital systems are moving toward having part of their staff certified to do that, most generally are not. We need help from our certifiers in understanding the documents used to apply testing from groups like the International Organization for Standardization, the Controlled Environment Testing Association, NSF International, the American National Standards Institute, and the American Society of Heating, Refrigerating and Air-Conditioning Engineers.”

Before an inspector or accreditor even arrives at your facility, Ms. Ashworth said, you should know and understand: • your cleanrooms’ testing results; • reasons for and outcomes of any plan of action; • how to detect any trends; and • how to troubleshoot problem areas using techniques such as smoke testing.

“I like to equate my partnership with our certification company with my scuba diving equipment certifier,” Ms. Ashworth said. “I don’t want to find out when I’m 60 feet underwater that my regulator or computer isn’t working correctly. I have to have my equipment certified annually. Similarly, let’s take a ‘safety stop’ in the cleanroom and read our reports and look at all the details in them—then we don’t have to take a longer ‘safety stop’ later.”

Cleanroom certification reports can take many forms, she said. “They’re unique to each company. They will have the same things in the report, but they may not be in the same place or look the same, so you have to familiarize yourself with the components, where you find them and how they are organized.

“Sit down with your certifier and ask questions about these reports. Get in the cleanroom with them and ask questions,” Ms. Ashworth said. “Have them do some examples for you: How are particle count tests in the hood performed? What in those hoods can affect it? Open up a needle by the particle counter and see if that makes the counts go up. Pop the needle open inappropriately from the package and see how many more particles that makes—or does it? Tearing apart needles and different things in the hood, all of these are great examples that you can use to explain these reports and links to behavior in the cleanroom to your staff.”

Certification companies should assess the following: • laminar airflow workbenches (hoods) and biological safety cabinets; • viable air and surface sampling; • HEPA filter integrity; • nonviable airborne particle counts; and • viable air sampling.

She advised reviewing room identification reports carefully and ensuring that maps on each report are drawn correctly, with proper placement of hoods, ceiling HEPA filters and lights, and negative pressure rooms, positive pressure rooms, anterooms and other areas labeled correctly, with correct and up-to-date room occupancy.

“Ensure that sampling locations are identified correctly on the map and that the number of sampling locations is accurate,” Ms. Ashworth said. “There can be transcription errors in reports, and just as we put scrutiny on our prescriptions for our patients, we need to put similar scrutiny on these reports.”

A Crucial Role for Partnerships

A good partnership with your certifier can identify areas where you need more viable sampling, noted Abby Roth, the senior director of business operations at CriticalPoint, during the Compounding Pharmacies Grand Salon. “Your certifier can provide you with particle counts per location, and in some areas, you may see a higher particle count than others because of the way air moves through the room and where your return grills are located.”

While doing HEPA testing, certifiers can also help you determine the load on your HEPA filters and when you may need to change them, Ms. Ashworth said. “You don’t want to find out when you’re in your biannual testing that that’s when you need filters, especially right now when there’s such a short supply of everything.”

When it comes to remediation and plans of action, Ms. Ashworth said, there can be many different approaches, but certain information should always be included: • the date the report was written; • the date testing occurred; • who receives the information; • results of testing or equipment failure/replacement, including description of viable organisms and how many; • pictures, if available; and • next steps: who, when, where, what, how and why.

“We can be inspected by many agencies at any time,” Ms. Ashworth said. “Be sure you know your reports, you’ve read them thoroughly and documented them, and have a great relationship with your certifier.”

hes s ety plin ng; e coun nts st ;

—Gina Shaw

The sources reported no relevant fi nancial disclosures.

set, and we want to see which bugs are transferred on those materials.”

Door handles of pass-throughs. That’s a “maybe” location, depending on where it is located. “The door handle of a pass-through in your ISO 8 anteroom, for example, may or may not be sampled,” she said. “If the passthrough lives on the dirty side and goes through to the unclassified space, it’s likely that people are not wearing gloves to reach in and there will be an astronomical number of bugs on that handle, which may or may not be a problem, depending on your compounding process. For a door handle on a pass-through from the ISO 8 into the buffer room, you should look at your workflow and practice. Ideally, someone passing something from your Class 8 into the buffer room is wearing gloves. If they are, sample the handle and see what’s there. If they’re not, you need to talk about material handling.”

Refrigerators. “You might have a pass-through fridge that lives between your unclassified space and the anteroom, or the anteroom and the buffer room. You need to watch work practice and see how people are utilizing this refrigerator,” Ms. Roth said. “If you have a lot of back-and-forth to it that could directly impact the sterility of the compounded sterile preparation, by all means take samples there to track the movement of microorganisms.”

What about door handles in general? It depends on your setup. More and more systems have moved to hands-free doors, in which case sampling is probably unnecessary. At University Hospitals of Cleveland, the vast majority of doors are now hands-free after a 2017-2018 construction project, Dr. Gegorski said. “Those sites that updated their cleanrooms prior to getting capital for the larger project may still have manual doors. But honestly, we haven’t found door handle sampling to be all that valuable anyway, because we are also obsessively cleaning those daily.”

Sinks and benches. These are another “maybe” location. “It is difficult to sample around a freestanding sink,” Ms. Roth said. “But if you have a sink incorporated into a longer countertop, with water splashing onto that counter, and people are putting things down on the counter that will be carried into the buffer room, sampling on the sink might be valuable in the short term. But in the long term, I’d rather have you change work practices so people don’t put things next to that sink. And please don’t sample inside the sink. There will be a ton of microorganisms, even with daily cleaning. For benches, if you have staff that put things on your garbing bench that ultimately end up in the primary engineering control, you might want to sample the bench. But again, what you really want to do is change that work practice. The only thing that should be going on the bench is somebody’s backside.”

Walls and floors. As for what can be skipped, “nobody should be sampling walls,” Ms. Roth said. “If your staff are touching the walls before they enter the primary engineering control, you need to do some retraining, figure out why and change work practices so that is not an issue,” Ms. Roth said. “Nobody should be sampling floors. And unless you’re compounding on the floor, you can skip sampling there, especially in the anteroom. An ISO 8, in particular, and on the dirty side especially, will be loaded with microorganisms. There should be less on the clean side, but this also is why the chapter requires cleaning the floor daily to mitigate the risk of organisms present on the floor.”

The point of monthly surface sampling, Dr. Gegorski said, is to paint a picture of microbial control in the space. “You want to choose locations that will help you assess how well you are behaving in the space, how well your garbing is going and how well your cleaning practices are being maintained.” —Gina Shaw

340B Program, PAPs Help Ensure SP Rx Success

Actively managing participation in the federal 340B Drug Pricing Program, coupled with efforts to boost financial assistance and medication access, can help maximize savings and ensure the overall success of specialty pharmacy services, a panel of experts said during the 2021 ASHP Conference for Pharmacy Leaders, held virtually.

For example, when the FDA approved the pediatric cystic fibrosis medication elexacaftor-tezacaftorivacaftor (Trikafta, Vertex) in June, the specialty pharmacy team at Atrium Health Wake Forest Baptist, in WinstonSalem, N.C., worked with eligible patients and their families to ensure they were completing necessary lab tests and education counseling during clinic visits leading up to the approval so patients would be ready, said Regina Schomberg, PharmD, BCPS, the system director of pharmacy, retail and specialty pharmacy services. With the help of a medication access specialist, they were able to obtain prior approval for 19 patients within one week of the FDA approval, and all patients were able to have their prescriptions sent either to the hospital’s internal specialty pharmacy or another specialty pharmacy within the first week.

Dr. Schomberg and her colleagues also were able to use 340B savings to support pharmacy staff to continue providing personalized care to this vulnerable population.

Transplant Help

Solid-organ transplant patients also can benefit from ongoing specialty pharmacy care and 340B funding. “Financial assistance continues to be the largest barrier these patients experience,” Dr. Schomberg said. “You can imagine the severity of a patient being overwhelmed with the desire to continue with their newly transplanted organ, and then also have to grapple with the need for finance assistance.”

During a patient outreach call, one of her pharmacy technicians discovered that a patient had lost their job two months before, was at risk for losing insurance coverage, and had been paying out of pocket for the medication. The patient shared they were a few days from being out of medication and didn’t have the funds to pay for the new script. The pharmacy technician found a patient assistance program (PAP) and contacted the manufacturer for approval within a few days.

Year to date, Dr. Schomberg and her colleagues’ work on PAPs has garnered millions of dollars of medication savings. They also use a computerized system that allows searching for PAP, foundation or grant funding, and they keep track of the paperwork to assist patients. Their efforts to maximize 340B savings also have paid off. But Dr. Schomberg stressed that the program doesn’t just benefit patients; at her institution, 340B savings also are invested in staff, including two designated medication access specialists fully devoted to PAPs.

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Dr. Schomberg reported no relevant fi nancial disclosures.

Web Exclusive

For UC Davis Health System’s approach to helping transplant patients access affordable medications, see expanded version of this article at www. pharmacypracticenews.com.

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